UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005353 |
|---|---|
| Receipt number | R000005811 |
| Scientific Title | the study about the improvement of the outcome of catheter ablation for atrial fibrillation to the patients with hypertension |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2017/04/06 03:07:28 |
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Basic information
Public title
the study about the improvement of the outcome of catheter ablation for atrial fibrillation to the patients with hypertension
Acronym
the study about the improvement of the outcome of catheter ablation for atrial fibrillation
Scientific Title
the study about the improvement of the outcome of catheter ablation for atrial fibrillation to the patients with hypertension
Scientific Title:Acronym
the study about the improvement of the outcome of catheter ablation for atrial fibrillation
Region
| Japan |
Condition
Condition
atrial fibrillation
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the efficacy of mineralocorticoid receptor antagonist eplerenone for the outcome of catheter ablation for atrial fibrillation to the patients with hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eplerenone was administered at a dose of 50mg daily.
Interventions/Control_2
An antihypertensive drug except for eplerenone.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with drug refractory atrial fibrillation and hypertension
Key exclusion criteria
Patients were excluded if they had contraindications to ARBs and/or aldosterone inhibitor; had recently (within the previous 3 months) had an acute myocardial infarction, coronary bypass operation, or percutaneous
coronary intervention; had clinically significant valvular disease; had thyroid dysfunction; were pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Cardiology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
kaonuma@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Cardiology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
Homepage URL
kaonuma@md.tsukuba.ac.jp
Sponsor or person
Institute
Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 31 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005811
